Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Trial ID or NCT#
NCT04511026
Status
NOT RECRUITING
Purpose
The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.
Official Title
Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * The patient has histological diagnosis of cancer of the endometrium of any histology or grade.* The patient should have received no prior treatment for her endometrial cancer.* The patient has clinically uterine confined disease.* The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care.* The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2.* If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.* The patient has provided written informed consent.* The patient is at least 18 years of age at the time of consent
Exclusion Criteria:
- * The patient has clinical or radiological evidence of metastatic disease.* The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix.* The patient has participated in another investigational drug study within 30 days of scheduled surgery.* The patient has an iodine allergy.* The patient is pregnant or lactating.
Investigator(s)
Amer Karam
Gynecologic oncologist
Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology
Contact us to find out if this trial is right for you.
Contact
Sujatha Kalle
650-724-3308
View on ClinicalTrials.gov
